When a clinical trial progresses, the formulation itself and the dosage form may change. As a result, sponsors may also want to consider the desirable commercial format in later stage clinical studies.
In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progression of stages ranging from drug discovery, product development, clinical trials to full-scale commercialization or it is the transfer between development and commercialization at different sites within or outside an organization.
Experience has shown the transition from active shippers to passive shippers is mainly driven by three factors: cost-savings, availability, and ease of use.
Supply chain integrity is necessary to a pharmaceutical company’s success. When dealing with a multitude of suppliers spanning several geographies, manufacturing issues can arise if proper protocols are not in place. Specific challenges include product purity, regulatory compliance, safety, cost containment and quality assurance.
Audit processes are an integral component of supply chain management. Conducting an effective audit empowers pharmaceutical companies and their suppliers to raise performance levels and strengthen relationships while improving patient-care quality. The mutual benefits of a successful audit include:
SAFC’s CHOZN® Platform has been developed as a ‘plug and play’ manufacturing system for the creation of biopharmaceutical producing cell lines.
A whitepaper describing how a Unified Approach enhances the safety, simplicity and speed of clinical trials.
Santosh Vetticaden, Ph.D., M.D. is a drug development professional with over 20 years of experience spanning large pharma and biotech across multiple therapeutic areas. He has been involved in trials from Phase I-Phase IV and has been extensively involved in the design, planning, and implementation of global trials. By Rob Wright, Chief Editor, Life Science Leader magazine
Alkermes, through the merger with Elan Drug Technologies, to become Alkermes plc, has been developing and manufacturing commercial scale solid oral dosage products for over 40 years.
Two unique techniques, saccadic eye movements and pupillometry, help characterize pharmacodynamic drug effects in healthy subjects. This article explores how these techniques are being applied to investigate the side-effect profile of compounds, better understand the mechanisms involved in the pathophysiology of CNS disease states, and demonstrate target engagement of drugs.
Many different public and private organizations from across the globe are collaborating on neglected diseases drug-discovery and development projects with the aim of identifying a cure for tropical infectious diseases.